SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?

NCT ID: NCT02568930

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 694 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-15
• Study Completion Date: 2021-03-31

Brief Summary

The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination therapy [DT]) and their caregivers. Our study will contribute to better patient-centered care of older advanced HF patients and their caregivers, by informing decision making and guiding strategies to enhance post-operative HRQOL.

Detailed Description

The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination therapy [DT]) and their caregivers, risk factors for poor HRQOL, adverse event and symptom burden, and quality-adjusted life years (QALYs). Advanced HF patients, 60-80 years of age, are an appropriate target group for this study because they are receiving HTs and MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. Using a prospective, longitudinal design, our multi-site comparative effectiveness research will compare HRQOL outcomes in patients who receive HT or DT MCS and their caregivers, from baseline to 2 years post-operatively. The primary aim of this proposed study is to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, experience non-inferior change in overall HRQOL (primary), and domains of HRQOL (physical, mental, and social) from baseline through 2 years after surgery. Secondary Aims are (1.) to determine whether caregivers of older advanced HF patients who undergo DT MCS, compared to caregivers of older advanced HF patients who undergo HT, experience non-inferior change in overall HRQOL and domains from baseline through 2 years after surgery; (2.-3.) to identify risk factors related to poorer overall HRQOL in older DT MCS patients and their caregivers, as compared to older HT patients and their caregivers, at 2 years after surgery; (4.) to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, have non-inferior rates of freedom from adverse events & symptoms at 1 and 2 years after surgery; and (5) to evaluate the distribution of QALYs in older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT at 2 years after surgery. Our proposed study will contribute to better patient-centered care of older advanced HF patients and their caregivers, by informing decision making and guiding strategies to enhance post-operative HRQOL.

Conditions

Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Transplantation (HT)

The cohort includes advanced heart failure patients (60-80 years of age) listed for HT and their caregivers.

No interventions assigned to this group

Mechanical Circulatory Support (MCS)

The cohort includes advanced heart failure patients (60-80 years of age) scheduled for DT MCS and their caregivers.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Advanced HF and listed with the United Network for Organ Sharing (UNOS) for a "primary" HT or scheduled to receive a "primary" DT LVAD;

2. Ages 60-80 years and able to speak, read, and understand English;

3. Willing to participate and ability to provide informed consent.

1. Primary caregiver, identified by the patient, prior to DT MCS or while a candidate for HT;

2. Unpaid family member or friend who helps the patient with self-care;

3. Age > 21 years and able to speak, read, and write English;

4. Willing to participate and ability to provide informed consent.

Exclusion Criteria

1. Patient has a prior HT or MCS device

2. Patient is listed for multiple organ transplantation (i.e., heart/lung, heart/kidney, etc.)

Caregiver Exclusion criterion:

1) Patient refusal to participate.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Grady

Professor, Feinberg School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Grady, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Florida Hospital

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota Medical Center-Fairview Health Services

Minneapolis, Minnesota, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Columbia University

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University (OSU)

Columbus, Ohio, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

References

Nguyen DD, Spertus JA, Benton MC, Thomas M, Jones PG, Andrei AC, Wu T, Baldridge AS, Grady KL. Association of Patient Reported Outcomes With Caregiver Burden in Older Patients With Advanced Heart Failure: Insights From the SUSTAIN-IT Study. Circ Heart Fail. 2024 Jul;17(7):e011705. doi: 10.1161/CIRCHEARTFAILURE.124.011705. Epub 2024 Jun 24.

Reference Type: DERIVED

PMID: 38910557 (View on PubMed)

Chuzi S, Wilcox JE, Kao A, Spertus JA, Hsich E, Dew MA, Yancy CW, Pham DT, Hartupee J, Petty M, Cotts W, Pamboukian SV, Pagani FD, Lampert B, Johnson M, Murray M, Takeda K, Yuzefpolskaya M, Silvestry S, Kirklin JK, Wu T, Andrei AC, Baldridge A, Grady KL. Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study. Circ Heart Fail. 2023 Aug;16(8):e010038. doi: 10.1161/CIRCHEARTFAILURE.122.010038. Epub 2023 Jun 22.

Reference Type: DERIVED

PMID: 37345518 (View on PubMed)

Okwuosa IS, Anderson A, Petty M, Wu T, Andrei AC, Kao A, Spertus JA, Pham DT, Yancy CW, Dew MA, Hsich E, Cotts W, Hartupee J, Pamboukian S, Pagani F, Lampert B, Johnson M, Murray M, Tekeda K, Yuzefpolskaya M, Kirklin JK, Grady KL. Caregiver burden before heart transplantation and long-term mechanical circulatory support: Findings from the sustaining quality of life of the aged: Transplant or mechanical support (SUSTAIN-IT) study. J Heart Lung Transplant. 2023 Sep;42(9):1197-1204. doi: 10.1016/j.healun.2023.01.015. Epub 2023 Apr 21.

Reference Type: DERIVED

PMID: 37088337 (View on PubMed)

Grady KL, Kao A, Spertus JA, Hsich E, Dew MA, Pham DT, Hartupee J, Petty M, Cotts W, Pamboukian SV, Pagani FD, Lampert B, Johnson M, Murray M, Takeda K, Yuzefpolskaya M, Silvestry S, Kirklin JK, Andrei AC, Elenbaas C, Baldridge A, Yancy C. Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study. Circ Heart Fail. 2022 Oct;15(10):e009579. doi: 10.1161/CIRCHEARTFAILURE.122.009579. Epub 2022 Oct 10.

Reference Type: DERIVED

PMID: 36214123 (View on PubMed)

Grady KL, Andrei AC, Elenbaas C, Warzecha A, Baldridge A, Kao A, Spertus JA, Pham DT, Dew MA, Hsich E, Cotts W, Hartupee J, Pamboukian SV, Pagani FD, Petty M, Lampert B, Johnson M, Murray M, Takeda K, Yuzefpolskaya M, Silvestry S, Kirklin JK, Yancy C. Health-Related Quality of Life in Older Patients With Advanced Heart Failure: Findings From the SUSTAIN-IT Study. J Am Heart Assoc. 2022 Feb 15;11(4):e024385. doi: 10.1161/JAHA.121.024385. Epub 2022 Feb 12.

Reference Type: DERIVED

PMID: 35156421 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG047416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00200851

Identifier Type: -

Identifier Source: org_study_id